Informed Consent Overview

For most research, informed consent is documented in writing to provide key information about the research. The consent form should:

provide information for the subject's current and future reference, and

document the interaction between the subject and the investigator.

However, even if a signed consent form is used, it alone does not create an adequate consent process. "The informed consent process is an ongoing exchange of information between the investigator and the subject and could include, for example, use of question and answer sessions, community meetings, and videotape presentations. In all circumstances, however, individuals should be provided with an opportunity to have their questions and concerns addressed on an individual basis." (OHRP: http://answers.hhs.gov/ohrp/categories/1566)

Please refer to the following guidance documents or links with your specific research questions: